Comparison of the use of cauterization and scalpel in abdominal vascular surgery incision in hysterectomy patients
Design
Sampling was convenience. A total of 100 women undergoing hysterectomy with transverse incision in Imam Sajjad Hospital in 2020 who are eligible for the study are selected and then randomly divided into two groups: scalpel and cauterization.
The rate of postoperative infection in both scalpel and cauterization groups, the rate of wound opening in both groups one month after surgery, pain in the first, second and eighth days after surgery and postoperative bleeding in both groups, were assessed.
Settings and conduct
After receiving the code of ethics from Yasouj University of Medical Sciences, the researcher refers to Imam Sajjad Hospital. Sampling was convenience. A total of 100 women undergoing hysterectomy with transverse incision in Imam Sajjad Hospital in 2020 who are eligible for the study are selected and then randomly divided into two groups: scalpel and cauterization. For this purpose, 7 blocks of 6 and 5 blocks of 10 were selected and the samples were assigned to the scalpel and electrocautery groups (46 people in each group), respectively.The rate of postoperative infection in both scalpel and cauterization groups, the rate of wound opening in both groups one month after surgery, pain in the first, second and eighth days after surgery and postoperative bleeding in both groups, were assessed.
Participants/Inclusion and exclusion criteria
The study population is women who underwent hysterectomy with transverse incision in 2020 in Imam Sajjad Hospital in Yasuj.
Intervention groups
All women living in Yasuj who underwent using cauterization and scalpel and do not have coagulation disorders.
Main outcome variables
the rate of wound infection after surgery, pain in the first, second and eighth days after surgery and postoperative bleeding
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20200919048762N1
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Parvin Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3100 1000
Email address
parvin.ghafari@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
2019-12-01, 1398/09/10
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Comparative assessment of the complication of using electrocauterization and scalpel in abdominal wall incision in hysterectomy
Public title
Complication of abdominal wall incision in hysterectomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All women living in Yasuj who underwent 2020 using cauterization and scalpel and do not have coagulation disorders.
Exclusion criteria:
Reluctance to participate in the study
Age
From 20 years old to 69 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization
For this purpose, 7 blocks of 6 and 5 blocks of 10 were selected and the samples were assigned to the scalpel and electrocautery groups (46 people in each group), respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8913737111
Approval date
2019-07-11, 1398/04/20
Ethics committee reference number
IR.YUMS.REC.1399.049
Health conditions studied
1
Description of health condition studied
hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
the rate of wound infection one month after surgery, the pain in the first, second and eighth days after surgery, bleeding after the operation
Timepoint
one month after surgery and the first, second and eighth days after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: scalpel and cauterization groups
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام سجاد یاسوج
Full name of responsible person
Parvin Ghafari
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8313711137
Phone
+98 74 3100 1002
Email
parvin.ghafari@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8313737111
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghafari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8313737111
Phone
+98 74 3334 6078
Email
parvin.ghafari@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghafari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8313737111
Phone
+98 74 3334 6078
Email
parvin.ghafari@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghafari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8313737111
Phone
00987431000
Email
parvin.ghafari@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data is available to everyone after the results are published.
Under which criteria data/document could be used
Anyone can contact the researcher via the her email.
From where data/document is obtainable
Anyone can contact the researcher via the her email or mobile phone number.
What processes are involved for a request to access data/document
He/ she can receive a response within a maximum of two weeks.